QC Analyst -Shift

Requirements

Responsibilities:

• Work as directed by the QC Manager / Associate Director,
  according to Company safety policies, cGMP and cGLP.
  
• Required to drive compliance with our Global policies,
  procedures and guidelines and regulatory requirements and execute Good
  Manufacturing Practices (cGMP) in the performance of day to day activities and
  all applicable job functions.
  
• Required to comply with our Global Policies, Procedures
  and Guidelines, regulatory requirements and execute current Good Manufacturing
  Practices (cGMP) in the performance of day to day activities and all applicable
  job functions.
  
• Develop, implement and maintain procedures that comply
  with appropriate regulatory requirements.
  
• Ensure that all Quality Systems within the department are
  adhered to on a daily basis.
  
• Operate as part of the QC team performing the allocated
  testing and laboratory -based duties.
  
• Ensure timely completion of all assigned data processing
  and reviewing.
  
• Ensure timely completion of Laboratory Investigation
  Reports and deviations through site procedures
  
• Participate in the timely generation of trend data,
  investigations, nonconformances, validation protocols, reports in support of
  method validation/verifications and equipment qualifications.
  
• Participate in QC Tier 1 daily meetings and ensure
  effective communication of testing progress, deviations etc.
  
• Peer review testing documentation and ensuring data
  integrity compliance and QC Right First Time KPIs are achieved.
  
• Where applicable, review, approve and trend test results.
  
• Participate in the laboratory aspects of OOS
  investigations.
  
• Provide support with audit/inspection requirements to
  ensure department compliance/readiness.
  
• Participate in internal and external audits and
  inspections, taking the role of auditee for assigned areas of responsibility.
  
• Drive continuous improvement, perform root cause analysis
  on system failures and substandard equipment performance, using standard tools
  and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams,
  5 why's etc,
  
• Work collaboratively to drive a safe and compliant
  culture
  
• May be required to perform other duties as assigned.
  

Reporting Structure: Reports to QC Manager

Qualifications & Experience - Knowledge &
Skills:

Technical

• Knowledge of regulatory/ code requirements to Irish,
  European and International Codes, Standards and Practices.
  
• Knowledge of cGMP
  
• Laboratory Quality Systems
  
• Proficiency in Microsoft Office and job -related computer
  applications required
  
• Report, standards, policy writing skills required
  
• Understanding of Lean Six Sigma Methodology preferred.
  
• Immunoassay and cell culture experience preferable
  

People

• A great communicator, decisive decision -maker with a
  proven ability to deliver excellence
  
• Ability to participate in highly -effective teams.
  
• The desire to continuously learn, improve and develop.
  
• Strong leadership and interpersonal skills.
  
• Willingness to support the team and a strong focus on
  delivering excellence.
  
• High personal integrity, credibility, energy and
  flexibility.
  
• Model the leadership behaviours and use the MPS
  principles to achieve success.
  
• Set clear performance standards; overcome obstacles; hold
  ourselves and others accountable for achieving results.
  
  

Education:

• Bachelor’s Degree or higher preferred; ideally in a
  science related discipline.